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Идёт набор NCT06902571

Cross-validating the iTBS-induced Hemodynamic Response From fNIRS and fMRI: a Concurrent iTBS-fMRI-fNIRS Study

— Наблюдательное Healthy Adults

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intermittent theta burst stimulation (iTBS).
Кому может быть актуально
Состояния в реестре: Healthy Adults. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
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Обзор

Intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) is well established in treating patients with major depressive disorder (MDD). However, the iTBS-induced hemodynamic response during or immediately after a full session of stimulation has not been fully investigated. Although several concurrent iTBS/functional Near Infrared Spectroscopy (fNIRS) and iTBS/functional magnetic resonance imaging (fMRI) studies have investigated the hemodynamic response during or immediately after left DLPFC iTBS, they revealed inconsistent findings in the stimulated DLPFC. Given that the variability in iTBS-induced hemodynamic response in the stimulated DLPFC could be modulated by various inter- and intra-individual factors, cross-validating the findings from both techniques (fNIRS and fMRI) in the same group of participants under the same conditions through a simultaneous fMRI/fNIRS setting enables a straightforward comparison and interpretation of results from each technique. However, to our knowledge, cross-validation of iTBS-related fNIRS and simultaneous fMRI data has not been conducted yet, even the implementation of a simultaneous iTBS/fMRI/fNIRS setup is technically feasible with the mutually compatible equipment. Therefore, the current study has two primary objectives: Firstly, to establish a novel and practical methodological pipeline for simultaneously conducting iTBS/fMRI/fNIRS. Secondly, to cross-validate the hemodynamic responses during and immediately after iTBS, respectively monitored by fNIRS and fMRI.

Вмешательства

  • Устройство Intermittent theta burst stimulation (iTBS)
    600 pulses (3 pulses × 10 bursts × 20 trains = 600 pulses) will be delivered each session with reference to a 3-minute protocol developed by Huang, et al. (2005). Before, during and after iTBS, both fNIRS and fMRI measurements will be conducted simultaneously.

Первичные конечные точки

  • Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline [Срок оценки: Before, during and after iTBS stimulation, up to 15 minutes]
  • BOLD signals [Срок оценки: Before, during and after iTBS stimulation, up to 15 minutes]

Критерии участия

Критерии включения

  • healthiness based on history and psychiatric assessment

Критерии исключения

  • a medical history of a major systemic illness or a neurological or psychiatric disorder
  • pregnancy
  • common fNIRS, MRI and TMS exclusion criteria such as a history of brain surgery, head injury, cardiac pacemaker, intracranial metallic particles or a history of seizures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT06902571 · HSEARS20231218001-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗